• 대한예방한의학회지
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• 제28권1호
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• 한국항해항만학회지
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• 제37권6호
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• pp.709-718
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• 2013

In this study, AHP analysis was conducted through a survey that was organized by 9 job categories. The results show that sustainable operation risks have the highest priority level among all criteria with management interest having the highest priority level within sustainable operation risks related attributes. The most important risk attributes among stakeholder risks appeared to be asset security and cargo and conveyance security, with education and training being the most important among regulatory risks. Effective management and response to the risks from export controls on strategic trade require an understanding of supply chain security and compliance programs, effective training programs, investments for development of security systems that meet international standards. In addition, the government needs to focus on developing professionals and providing support for companies with compliance programs, working closely with businesses.

• Nuclear Engineering and Technology
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• 제37권3호
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• pp.231-244
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• 2005

In recent decades, significant effort has led to risk-informed improvements to regulation. Performance-based approaches also promise significant gains in efficiency (level of safety versus effort). However, significant work remains to be done before performance-based approaches realize their full potential in regulation of nuclear power plants. This paper reviews key concepts related to performance-based regulation, discusses some applications of performance-based approaches, and identifies issues that still need to be addressed. Realistic, experience-based models of licensee performance are still lacking; this makes it difficult to assess the prospective effectiveness of any given regulatory approach, in light of the performance issues that it will actually face. Also, while 'compliance' is an intuitively straightforward concept to apply within a prescriptive implementation, its analog in a performance-based approach remains unclear. An overarching theme of the paper is that formal methods of decision analysis are very helpful in developing appropriate regulatory approaches, especially performance-based ones; this theme is illustrated at several points.

• 한국지진공학회:학술대회논문집
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• 한국지진공학회 1999년도 춘계 학술발표회 논문집 Proceedings of EESK Conference-Spring
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• pp.17-24
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• 1999

The porvision against earthquakes and aseismic design of nuclear power plants (NPPs) in Korea are composed of four stages: site-selection, design, construction, and operation stages, Since regulatory criteria are strictly applied in each stage, the NPPs in Korea are believed to have a sufficient safety against maximum potential earthquakes. However, it has been recognized that those regulatory criteria borrowed from U.S. should be replace by Korea-specific ones by using earthquake data obtained from earthquake observation at and around NPP sites. Also, the government made a plan after the Yongwol and th Kyongju earthquakes that the regulatory body operates an independent earthquake network in order to reinforce the earthquake preparedness of NPPs. In compliance with the government's plan, this project is aiming at deployment of an earthquake motoring network composed of four seismic stations at NPP sites to record earthquake ground motions at NPP sites, to derive attenuation formulas of various ground motions and site-specific response spectra, and to develop structural intergrity assesment program.

• 자원ㆍ환경경제연구
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• 제17권4호
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• pp.775-812
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• 2008

본 연구는 양도성개별할당량(individual transferable quota:ITQ)제도하에서 어획량 보고 시스템과 관련된 뉴질랜드의 독특한(unique) 어획량균형제도(Catch Balancing Regime)인 추정가치(deemed value) 시스템의 시행전략에 관한 한 이론적 모델을 제시한다. 본 논문에서 제시된 시행전략모델은 현시원칙(revelation principle)과 유인합치성(incentive compatibility)이론에 근거한 이론적 실증 분석에 기초한다. 분석 결과, 뉴질랜드에서 시행되고 있는 추정가치 시스템은 ITQ 제도하에서 지금껏 규제의 사각지대로 여겨졌던 부수어획(bycatch)과 불법투기(discarding), 그리고 남획(overfishing)과 같은 난제들을 통제 조정할 수 있는 가치 있는 제도적 메커니즘을 가지고 있는 것으로 나타났다. 다시 말해, 분석된 추정가치 시스템에 의한 어획량균형제도의 시행은 우선, 쿼타 보유자들의 어획보고에 대한 규제순응(regulatory compliance)을 향상시키고, 둘째, 어업의 감시 감독(surveillance monitoring)에 대한 비용을 안정화시키며, 셋째, 어자원의 지속적 효율적 관리에 대한 긍정적 유인을 제공한다.

• 한국콘텐츠학회논문지
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• 제11권2호
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• pp.61-68
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• 2011

인터넷의 급격한 발달로 인해 수많은 기업에서 다양한 어플리케이션들이 불특정 다수의 사용자에게 개방되어 있는 현재의 비즈니스 환경에서 최근 개인정보의 보안에 대한 이슈가 자주 언급되며, 그 중요도 측면에서 기업의 최우선 과제가 되었다. 얼마 전 정부에서도 정보통신망법 상의 개인정보 보호 강화조치를 법률로 제정하고 이를 다양한 산업군에 적용하고 있다. 기업은 개인정보의 보호를 위해 다양한 방안들을 마련해 이러한 규제를 준수하여, 내부에 관리중인 개인정보에 대해 보안을 강화하기 위해 빠르게 보안 솔루션을 도입하고 있다. 이에 수많은 데이터들이 저장되어 사용되고 있는 DBMS 측면에서 규제를 준수하는 동시에 효과적으로 데이터 보안을 확보하기 위한 방안을 암호화, 접근제어, 감사로 구분하여 각각에 대한 구현방법 및 해당 솔루션들을 비교 및 검토하여 이를 통해 최적의 데이터베이스 보안 방안을 모색할 수 있도록 체크리스트를 구현하였다.

• 융합보안논문지
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• 제22권1호
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• pp.113-120
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• 2022

기술 발달에 따른 기존 보안정책의 한계에도 불구하고 기업은 폐쇄적 보안정책을 유지함으로써 변화에 능동적으로 대응하지 못하고 있다. 본 연구는 정보보안 정책을 3가지 유형인 규제형 정책, 권고형 정책 그리고 고지형 정책으로 분류하였다. 분류된 각 정책의 유형은 확장된 계획행동이론을 적용하여 조직 구성원의 정보보안 정책 준수행동에 주는 영향을 규명하고 보안 스트레스의 조절효과를 살펴보았다. 각 요인들 간에 영향을 미치는 관계를 분석하기 위해서는 구조방정식모델링 기법인 SmartPLS 2.0과 SPSS 21.0을 활용하였다. 연구 결과 규제형, 권고형 그리고 고지형 정보보안 정책은 조직 구성원의 정보보안정책 준수행동에 영향을 주었으며 보안 스트레스는 계획된 행동이론의 선행요인인 정보보안 순응태도와 정보보안에 대한 주관적 규범에 영향을 주었다. 본 연구를 통해 기업의 정보보안 정책에 다양한 유형이 적용될 수 있음과 보안스트레스가 구성원의 정보보안 행동에 영향을 줄 수 있음이 제시되었다.

• 한국전자통신학회논문지
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• 제18권6호
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• pp.1177-1188
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• 2023

사회적으로, 조직들은 보유한 정보 자원의 엄격한 관리를 요구받고 있으며, 정보보안을 위한 기술과 정책에 투자를 높이고 있다. 반면, 조직원에 의한 정보 노출 위협은 지속해서 발생하고 있다. 연구의 목적은 보안정책에 의해 발생할 수 있는 업무 스트레스의 부정적 영향을 감소하는 방안을 제시하는 것이다. 세부적으로, 연구는 조직 환경(보안정책 목표 설정), 개인의 업무 지향성(조절초점) 요소를 반영하여, 업무 스트레스 완화 메커니즘을 제시하고자 하였다. 연구는 정보보안을 엄격하게 활용하고 있는 금융업 근로자에게 설문하였으며, 확보된 309건의 표본을 적용하여 가설을 검정하였다. 분석 결과, 연구는 보안정책 목표 관련 난이도와 구체성이 업무 스트레스(갈등, 모호성)를 감소시키고, 준수 의도에 영향을 주는 것을 확인하였다. 또한, 개인의 업무 향상 초점이 업무 스트레스와 상호작용 효과를 가져, 준수 의도에 미치는 부정적 영향을 축소할 수 있음을 확인하였다. 연구의 결과는 조직원의 보안 준수 강화를 위한 조직의 보안 전략 수립에 의미를 제공한다.

• Educational Technology International
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• 제22권2호
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• pp.139-167
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• 2021

After experiencing school closures and online learning caused by COVID-19, the important role of school education was reinforced. Elementary school is the foundation of life and allows students to develop both social and academic skills. The purpose of this study was to examine the mediational role of Self-Regulatory Skills (SRS) on the relationship between Maternal Parenting Attitude (MPA) and School Adjustment (SA) of elementary school students. A total of 99 students enrolled in an international school in Seoul, Korea from grades 3 to 6 participated in this study. Data were analyzed through Independent Sample T-Test, one way ANOVA, Multiple Regression Analysis, and Hierarchical Regression Analysis using the SPSS 23.0. The findings of the study were as follows. First, there is a difference between genders and among grades. Second, only acceptance was significantly related to school adjustment. Third, acceptance, strict control, and accepted control are significantly related to SRS. Fourth, Self-Regulatory Skills (Sustained Attention) fully mediate the relationship between Maternal Parenting Attitude (Acceptance) and School Adjustment (Academic Attitude/ Rule compliance). Educational implications for understanding the role of parenting attitude and future directions are discussed.

• 해양환경안전학회지
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• 제3권1호
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• pp.51-71
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• 1997

As passenger ship accidents so frequently have occurred, crisis consciousness is highly aroused in Korean society. Although bombastic policy guidlines were suggested in accordance with every passenger ship accident, there remains a still high possibility of such an accident reoccurring because passenger ship accidents occur from the perspective of non-compliance. The research objective of this study is to government's safety regulatory policies. Data for the analysis was collected from literature review. A Case study related to passenger ship accident is adopted for the analysis. The research methods utilized in this study consist of extensive quantitative analysis of 138 passenger ship accidents which had happened over last 10 years from 1984 to 1993 in Korea and a qualitative analysis of the passenger ship accident of the Seohae Ferry in October 1993. The results of the quantitive analysis on the 138 passenger ship accidents are as follows; Seeing the accidents yearly, the accidents which occurred by policy non-compliance are still exist, only somewhat reduced as years gone by. Seeing the accidents from the perspective of types of accident, fire accidents and death and injury accidents had more non-compliance factors than contact accidents and one-side collision accidents, etc. had. Seeing the accidents from the perspectives of types of passenger ship, large ships like car ferries and general passenger ship accidents had more non-compliance factors than any other kinds of ships had. Seeing the accidents from the perspectives of tons of passenger ships, large ships weighing more than 1, 000 tons and small ships weighing less than 50tons contained a lots of non-compliance factors. The results of the qualitative analysis of the passenger ship accident of the Seohae Ferry in Octovber 1993 are as follows; From the viewpoint of the human factor, there were non-compliance to the recruiting of required number of qualified crew members and non-compliance to the rule which prohibited them from leaving port in bad weather and high wave conditions. From the viewpoint of the ship factor, there were defects in the ship. So we might say that there was non-compliance which was aroused from the lacks of technical skills. From the viewpoint of the administrative factor, there were many non-compliance factors such as sailor education, shipping management, rescue, safety equipment. From the viewpoint of the passenger factor, there were passengers' threats which compelled the crews to leave the port under bad weather conditions. In conclusion, the principal non-compliances factors are passenger ship company did not follow safety rules such as shipping the permitted number of passengers, loading permitted tons of freight and fastening freights properly and recruiting required number of qualified crew. In order to reduce accidents, firstly we should find out the causes which play key roles in passenger ship companies' non-compliance to the government's safety regulations. Secondly we should tackle the causes.